AtrophyEarly Phase 1NCT07699367
Metformin and ACLR Muscle Recovery
A Early Phase 1 study testing Metformin in people with Atrophy and Inflammation, run by University of Utah at 1 site in United States.
Trial summary
The purpose of this research study is to determine if Metformin taken after anterior cruciate ligament reconstruction (ACLR) surgery can decrease muscle fibrosis, cellular senescence and improve leg strength. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Atrophy, Inflammation, Weakness, Muscle
- What is being tested?
- Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 1 Oct 2032
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 40y and older
- BMI: <30 kg/m2
- Full thickness ACL tear
- Less than 6 months between ACL injury and scheduled ACLR
Who cannot join
- Prior ACL tear in limb scheduled for reconstruction or current bilateral ACL tear
- Total knee dislocation
- Anticipated quadriceps ACLR grafts
- Current infection near the lower limb
- Inability to attend physical therapy sessions
- Post-operative loading restrictions
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- History of cardiovascular disease (e.g., CHF, CAD, MI, CVA)
- History of endocrine or metabolic disease such as hypo/hyperthyroidism and diabetes (Treated hypo/hyperthyroid for at least 6 months will be permitted)
- History of stroke with motor disability
- History of respiratory disease (acute upper respiratory infection, history of chronic lung disease)
- Self-reported pregnancy
- Bleeding disorder
- Implanted electronic devices (e.g., pacemakers, electronic infusion pumps, stimulators)
- Cancer or history of successfully treated cancer (less than 1 year) other than basal cell carcinoma
- Chronic systemic corticosteroid use (≥ 2 weeks) within 4 weeks of enrollment and for study duration (intra-articular/topical/inhaled therapeutic or physiologic doses of corticosteroids will be permitted)
- Androgens or growth hormone within 6 months of enrollment and for study duration (topical physiologic androgen replacement will be permitted)
- Currently taking estrogen products (topical estrogen products will be permitted)
- Taking anticoagulant medication (warfarin/Coumadin, heparin) that may complicate the muscle biopsy
- Any staff members who report directly to the principal investigators
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Metformin and Muscle Recovery Following ACL Surgery
The purpose of this research study is to determine if Metformin taken after anterior cruciate ligament reconstruction (ACLR) surgery can decrease muscle fibrosis, cellular senescence and improve leg strength. ACL injury and surgery increase muscle collagen content and inflammation which slows the recovery of muscle and function and ultimately impacts the quality of life. Individuals enrolled in the study will be randomized to receive metformin (or placebo) for 4 months after surgery. The investigators will measure muscle strength and inflammatory markers in muscle biopsy samples after the intervention period. Investigators will also follow up with participants 8 months later to determine the lasting effects of the intervention.
- Conditions
- Atrophy, Inflammation, Weakness, Muscle
- Being tested
- Metformin, Placebo
- Medical subject headings
- Atrophy, Inflammation, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Individuals randomized to the metformin group will take metformin daily (up to 2grams/day) for 4 months following ACLR surgery.
PlaceboOther
Individuals randomized to the placebo will take the same number of pills as the metformin group daily over a 4 month period following ACLR surgery.
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Experimental | Individuals randomized to metformin group will take the intervention daily for 4 months after ACLR surgery Receives: Drug: Metformin |
| Placebo | Placebo comparator | Individuals randomized to placebo group will take the treatment daily for 4 months after ACLR surgery Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thigh Muscle Fibrosis
Muscle collagen content (% Sirius Red Stain) will be measured in muscle biopsy samples from the involved thigh after 4 months of treatment and compared between the metformin and placebo groups.
Measured: Measured at 4 months after ACLR surgery
Thigh Muscle Cellular Senescence
Muscle cellular senescence (% SA Beta galactosidase) will be measured in muscle biopsy samples from the involved thigh after 4 months treatment and will be compared between the metformin and placebo groups
Measured: Measured at 4 months following ACLR surgery.
Knee extensor muscle strength
Knee extensor muscle strength from the involved leg (maximal voluntary isometric contraction; force) will be measured using an isokinetic dynamometer after 4 months of treatment and compared between the metformin and placebo groups.
Measured: Measured at 4 months following ACLR surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Oct 2031 (estimated)
- Study completion1 Oct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtrophyStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Micah Drummond, University of Utah
- Investigators
- Micah Drummond, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07699367
- Sponsor's protocol ID
- 204197
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IPD can be requested by the PI, Dr. Micah Drummond.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metformin and Muscle Recovery Following ACL Surgery
- ClinicalTrials.gov ID
- NCT07699367
- Acronym / sponsor ID
- 204197
- Conditions
- Atrophy, Inflammation, Weakness, Muscle
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Oct 2031 (estimated)
- Study completion
- 1 Oct 2032 (estimated)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to determine if Metformin taken after anterior cruciate ligament reconstruction (ACLR) surgery can decrease muscle fibrosis, cellular senescence and improve leg strength. ACL injury and surgery increase muscle collagen content and inflammation which slows the recovery of muscle and function and ultimately impacts the quality of life. Individuals enrolled in the study will be randomized to receive metformin (or placebo) for 4 months after surgery. The investigators will measure muscle strength and inflammatory markers in muscle biopsy samples after the intervention period. Investigators will also follow up with participants 8 months later to determine the lasting effects of the intervention.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin | Experimental | Drug: MetforminIndividuals randomized to metformin group will take the intervention daily for 4 months after ACLR surgery |
| Placebo | Placebo comparator | Other: PlaceboIndividuals randomized to placebo group will take the treatment daily for 4 months after ACLR surgery |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 40y and older
- BMI: <30 kg/m2
- Full thickness ACL tear
- Less than 6 months between ACL injury and scheduled ACLR
Key exclusion criteria (19 listed)
- Prior ACL tear in limb scheduled for reconstruction or current bilateral ACL tear
- Total knee dislocation
- Anticipated quadriceps ACLR grafts
- Current infection near the lower limb
- Inability to attend physical therapy sessions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminIndividuals randomized to the metformin group will take metformin daily (up to 2grams/day) for 4 months following ACLR surgery. | Drug | Metformin |
| PlaceboIndividuals randomized to the placebo will take the same number of pills as the metformin group daily over a 4 month period following ACLR surgery. | Other | Placebo |
Primary outcome
Thigh Muscle Fibrosis
Time frame: Measured at 4 months after ACLR surgery
Muscle collagen content (% Sirius Red Stain) will be measured in muscle biopsy samples from the involved thigh after 4 months of treatment and compared between the metformin and placebo groups.
Thigh Muscle Cellular Senescence
Time frame: Measured at 4 months following ACLR surgery.
Muscle cellular senescence (% SA Beta galactosidase) will be measured in muscle biopsy samples from the involved thigh after 4 months treatment and will be compared between the metformin and placebo groups
Knee extensor muscle strength
Time frame: Measured at 4 months following ACLR surgery
Knee extensor muscle strength from the involved leg (maximal voluntary isometric contraction; force) will be measured using an isokinetic dynamometer after 4 months of treatment and compared between the metformin and placebo groups.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No. IPD can be requested by the PI, Dr. Micah Drummond.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Micah Drummond principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Metformin in people with Atrophy and Inflammation, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Micah Drummond (801-213-2737, micah.drummond@hsc.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thigh Muscle Fibrosis (time frame: Measured at 4 months after ACLR surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.